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FDA 510(k) Application Details - K030650
Device Classification Name
Dye-Indicator, Ph (Urinary, Non-Quant.)
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510(K) Number
K030650
Device Name
Dye-Indicator, Ph (Urinary, Non-Quant.)
Applicant
URIDYNAMICS, INC.
6786 HAWTHORNE PARK DR.
INDIANAPOLIS, IN 46220 US
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Contact
MYRON RAPKIN
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Regulation Number
862.1550
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Classification Product Code
CEN
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More FDA Info for this Product Code
Date Received
02/28/2003
Decision Date
04/14/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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